The following data is part of a premarket notification filed by Kavo America with the FDA for Prophyflex 2, Model 2012.
| Device ID | K973876 |
| 510k Number | K973876 |
| Device Name: | PROPHYFLEX 2, MODEL 2012 |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | KAVO AMERICA ONE PRUDENTIAL PLAZA, 130 EAST RANDOLPH Chicago, IL 60601 |
| Contact | Gregory W Bowman |
| Correspondent | Gregory W Bowman KAVO AMERICA ONE PRUDENTIAL PLAZA, 130 EAST RANDOLPH Chicago, IL 60601 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-10 |
| Decision Date | 1997-12-19 |